Overview
Title
Importer of Controlled Substances Application: Catalent Greenville, Inc.
Agencies
ELI5 AI
Catalent Greenville, Inc. wants to bring special medicine parts from other countries for science projects, and people who care about this can say what they think before early March 2025.
Summary AI
Catalent Greenville, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to use these substances for developing bulk dosage formulations for research and clinical trials. People or organizations that have an interest in this matter can submit comments or request a hearing by March 3, 2025. Submissions can be made through the Federal eRulemaking Portal, and hearings request should be sent to the DEA at specified addresses.
Abstract
Catalent Greenville, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Keywords AI
Sources
AnalysisAI
Catalent Greenville, Inc. is seeking to register as an importer of controlled substances, as noted in a notice published by the Drug Enforcement Administration (DEA). The company's objective is to use these substances for the creation of bulk dosage formulations tailored for research purposes, clinical trials, and analytical studies. The public is invited to comment or object to this application, with the stipulation that all input must be submitted by March 3, 2025. People interested in engaging with this process can do so through an online portal specifically designed for public participation in rulemaking.
Significant Issues and Concerns
One of the primary concerns about this notice is the absence of specific details pertaining to the exact substances Catalent Greenville, Inc. wishes to import. The text alludes to "basic class(es)" of controlled substances but provides no specific names or drug codes. This lack of transparency could pose challenges for those interested in submitting informed comments or objections.
Another point of contention is the process of submitting comments. While the Federal eRulemaking Portal is a modern method for gathering public opinions, the notice indicates that comments are not immediately visible to the public upon submission. This delay may raise questions about transparency and the status of expressions of public opinion.
Furthermore, the instructions provided for using the eRulemaking Portal might be intricate for individuals unfamiliar with online regulatory processes. Such complexity could discourage public participation or inadvertently lead to errors in submission.
Impact on the Public and Specific Stakeholders
From a broad perspective, the document underscores the protocol for public participation in corporate regulatory processes involving controlled substances. However, without precise information about the substances in question, both public interest and participation might be limited. Individuals or groups concerned with drug policy, public health, or legal aspects of controlled substance management may find it challenging to engage deeply with the application process.
For specific stakeholders, such as local communities in Greenville, North Carolina, where the applicant is located, the potential impacts might be more pronounced. The development of research and clinical trial formulations could offer economic and scientific benefits, boosting local industry and potentially increasing job opportunities. Conversely, some might be worried about the handling and transportation of controlled substances in their area, depending on the substances' nature and associated risks.
Overall, the notice reflects a critical stage in regulatory oversight of controlled substances, inviting public scrutiny and input. Nonetheless, enhancing clarity regarding certain elements of the application could significantly affect the public's ability to participate meaningfully in the regulatory process.
Issues
• The document does not specify which basic classes of controlled substances Catalent Greenville, Inc. is applying to import, which could be unclear for those wanting to comment or object.
• The procedure for submitting comments suggests that comments are not instantly available for public view, which might lead to transparency concerns.
• The language regarding the ability to comment through the Federal eRulemaking Portal could be perceived as complex for individuals unfamiliar with the process.
• There is ambiguity on what specific drugs or drug codes are included under this application, as 'the following basic class(es) of controlled substance(s)' is mentioned but not specified.
• The notice does not specify what criteria will be used to determine if business activity is consistent with 21 U.S.C. 952(a)(2).